Bristol Myers Squibb’s Phase 3 ODYSSEY-HCM trial evaluating Camzyos (mavacamten) for the treatment of adult patients with symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM) did not meet its primary endpoints.

“The ODYSSEY-HCM trial, the largest and longest-duration study completed to date in patients with non-obstructive HCM, tested the hypothesis of whether a cardiac myosin inhibitor would improve measures of feel and function for these patients, showing clinical benefits similar to what we have seen in obstructive HCM,” said Milind Desai, MD, MBA, Vice Chair in the Heart, Vascular & Thoracic Institute and Director of the HCM Center, Cleveland Clinic. “The findings of this trial help us understand that obstructive HCM and non-obstructive HCM are two unique diseases. Through long-term trials and real-world data from thousands of patients with symptomatic obstructive HCM, we have seen the meaningful impact that Camzyos has on improving the quality of life for patients living with this condition. ODYSSEY-HCM indicates that we must consider new ways of thinking about potential treatment approaches for non-obstructive HCM.”

“While these results are disappointing, the ODYSSEY-HCM trial meaningfully contributes to the understanding of non-obstructive HCM, a disease where there remains a significant need for new treatment options,” said Roland Chen, MD, senior vice president, drug development, Immunology and Cardiovascular Medicines, BMS. “These findings represent the first Phase 3 clinical trial data for a cardiac myosin inhibitor in non-obstructive HCM. Importantly, these results do not change the favorable benefit-risk profile that has been consistently demonstrated across our Camzyos clinical trials in obstructive HCM and the robust body of real-world effectiveness and safety evidence showing its benefit for people living with obstructive HCM around the world.”